GenStrip blood glucose test strips, sold by Shasta Technologies may give incorrect blood glucose readings and should not be used, the U.S. Food and Drug Administration said today.

According to a report on Medscape.com:

A recall was issued after extensive quality control violations were found during a recent inspection of the company's Sherwood, Oregon plant.

Shasta's GenStrip test strips are "third-party" blood glucose monitoring test strips not made by the same company as the meter with which they are used, the FDA noted in a safety communication.

The test strips are advertised for use with the LifeScan OneTouch family of glucose meters (eg, Ultra, Ultra 2, and Ultra Mini). The FDA recommends using alternative glucose test strips that are designed for use with OneTouch meters.

The affected test strips have been manufactured and distributed since March 2013 and are available through online retailers and retail pharmacies. The strips may be packaged in green and white packaging with the GenStrip name on top.

A recent FDA inspection of Shasta found "extensive violations" of federal regulations intended to ensure the quality of products in the manufacturing of GenStrip test strips, which the FDA outlined in an April 8 warning letter to the company.

"Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. An inaccurate blood glucose reading could lead to inappropriate or delayed treatment that could significantly harm a patient," the FDA said.

To date, the company has been unwilling to recall their test strips voluntarily, resulting in their continued availability, the FDA said. Therefore, the FDA is recommending the test strips not be used. The FDA is also asking distributors and retailers of the test strips to discontinue sale and distribution of GenStrip glucose test strips and to remove unsold products from shelves.

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TIM DARRAGH has been reporting and editing the news for 30 years, most of it at The Morning Call. For much of that time, he's been doing award-winning investigative and in-depth reporting projects. Tim created the three-year-long Change of Heart project, and wrote a series on the state's fractured food inspection system that led to widespread improvements in food safety. Meantime, that novice jogger you see plodding along the streets around Bethlehem Township? That would be Tim.